Reported Dec 4, 2019 · Terminated
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
BALL NOSE GUIDE WIRE 80CM100CM. Item Nos. 281001080 281001100
- Product UsageThese instruments and delivery systems are used to facilitate implantation of orthopedic medical devices
- Lot codes and dates
- LOTS
355 of 355 codes
396280630880705620705640666290705650084760222820222830222840222850222860222880222890222900222910222920222930222940103057103058103059103061103062103063103064106566106567117023117024117026117027117028117029117030117032117033117033R117034135911135912135913135914135915135916135917135918164597164598164606164607164611164612206297206298206299206300206301206302206303
- FA4AK7A NXV7113R Y5XAP7000 ZV8AE7 UDI(01)00887868027857(17)231009(10)396280 (01)00887868027864(17)231016(10)830520
- LOTS
- Amount recalled
- 1729
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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